Aldara Precautions & Side Effects

Before Using ALDARA
In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For imiquimod, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to imiquimod or parabens. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - Imiquimod has not been shown to cause birth defects or other problems in humans. However, studies in animals using doses higher than recommended for humans have shown that imiquimod causes bone problems, brain problems, or low birth weight in pregnancies. Before taking ALDARA, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding - It is not known whether imiquimod passes into breast milk. However, ALDARA has not been reported to cause problems in nursing babies.

Children - Studies of ALDARA have been done only in adult patients, and there is no specific information comparing use of imiquimod in children up to 12 years of age with use in other age groups.

Older adults - Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of imiquimod in the elderly with use in other age groups. However, older adults may be more sensitive to the effects of imiquimod.

Other medicines - Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor and pharmacist if you are using any other topical prescription or nonprescription (over-the counter [OTC]) medicine that is to be applied to the same area of the skin.

Other medical problems - The presence of other medical problems may affect the use of imiquimod. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to imiquimod, parabens, or any ingredients in the productThis drug should not be used

• Inflamed skinMay make condition worse

• Lower immune response (your body is not able to fight infections as well)It is not known if imiquimod is safe to use with this condition

• Medicine that you have taken recently for the same skin problem or
• Surgery (recent)Imiquimod should not be used until the skin is completely healed from any previous treatments that you have had with medicine or surgery

• Sensitive to sunlightUse caution as you may have a higher risk of getting a sunburn

• SunburnShould not use until sunburn is gone

Precautions While Using ALDARA
If you notice severe skin irritation or flu-like symptoms (diarrhea, fatigue, fever, headache, or muscle pain), check with your doctor. It may be necessary for you to reduce the number of times a week that you use the medicine or to stop using the medicine for a short time until your skin is less irritated or your flu-like symptoms disappear.

Avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the cream off your skin before you engage in any sexual activity. Also, the medicine contains oils that can weaken latex (rubber) condoms, diaphragms, or cervical caps causing them not to work properly to prevent pregnancy.

Do not use any other skin product on the same skin area on which you use ALDARA, unless directed otherwise by your doctor.

Do not share your medicine with others, even if you think that they have the same condition you have.

Side Effects of ALDARA
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Blisters on skin, body aches or pain , chills, cough, difficulty in breathing, ear congestion , itching in genital or other skin areas, loss of voice, nasal congestion, open sores or scabs on skin, pain or tenderness around eyes and cheekbones, redness of skin (severe), runny nose, scaling, shortness of breath or troubled breathing , skin rash, sneezing, sore throat, stuffy or runny nose, tightness of chest or wheezing, unusual tiredness or weakness

Less common

Abdominal pain, dizziness and hoarseness , bladder pain, bloody or cloudy urine, cold flu-like symptoms, difficult, burning, or painful urination, fainting, fast or irregular heartbeat, frequent urge to urinate, high amount of cholesterol in the blood, lower back or side pain , lump in abdomen, persistent non-healing sore, pink growth on skin, reddish patch or irritated area, shiny bump on skin, white, yellow or waxy scar-like area

Symptoms of overdose

Flu-like symptoms, including diarrhea, fatigue, fever, headache, or muscle pain

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Burning or stinging of skin (mild), flaking of skin, pain, soreness, or tenderness of skin (mild), rash, redness of skin (mild), swelling at place of application

Less common

Lightening of the treated skin

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.